Hydralazine Hydrochloride

ANDA 87836, held by Strides Pharma Intl. Hydralazine Hydrochloride.

As of Nov 15, 2026, ANDA 87836 (Hydralazine Hydrochloride), held by Strides Pharma Intl, was first approved by FDA on Oct 5, 1982, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 5, 1982
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 5, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydralazine Hydrochloride10MG · tablet;oral	Hydralazine Hydrochloride	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Dec 11, 2001	Supplement 11Labeling	Approved	None posted
Nov 4, 1988	Supplement 10Labeling	Approved	None posted
Jul 14, 1988	Supplement 9Labeling	Approved	None posted
May 7, 1986	Supplement 4Manufacturing	Approved	None posted
Aug 10, 1983	Supplement 1Manufacturing	Approved	None posted
Oct 5, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87836
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters